Ryaltris Use In Pregnancy & Lactation

Effect on fertility: No studies on impairment of fertility have been conducted with olopatadine hydrochloride and mometasone furoate in combination; however, studies are available for the individual active components as described as follows.
Olopatadine hydrochloride: Olopatadine administered orally to male and female rats at dose of 400 mg/kg/day, (approximately 680 times the maximum recommended human dose (MRHD) for adults by intranasal administration on a mg/m² basis) resulted in decreases in the fertility index, number of corpora lutea and implantation rate. No effects on fertility were observed at a dose of 50 mg/kg/day (approximately 85 times the MRHD for adults by intranasal administration on body weight and mg/m² basis).
Mometasone furoate: In rats, impairment of fertility was not produced by subcutaneous doses up to 15 microgram/kg/day of mometasone furoate (less than the MRHD in adults by intranasal administration on a microgram/m² basis). As with other corticosteroids, at exposure levels associated with marked signs of systemic corticosteroid toxicity, mometasone furoate had progestogenic effects on the female reproductive tract and mammary glands.
Use in Pregnancy (Category B3): There are no adequate and well-controlled clinical studies with RYALTRIS, olopatadine hydrochloride only, or mometasone furoate only in pregnant women. No animal reproductive and developmental studies have been conducted with olopatadine hydrochloride and mometasone furoate in combination. Studies in animals with the individual active components are available and revealed teratogenicity and other adverse effects for mometasone furoate.
Olopatadine hydrochloride: Olopatadine was not teratogenic in rabbits and rats at oral doses up to 400 or 600 mg/kg/day, respectively (approximately 1,400 and 1,000 times the MRHD for adults by intranasal administration on a mg/m² basis, respectively).
Mometasone furoate: In animal studies, small quantities of mometasone furoate were found to cross the placenta barrier. Like other corticosteroids, at doses associated with signs of systemic toxicity, mometasone furoate reduced fetal growth and was teratogenic in mice, rats and rabbits after subcutaneous or topical application. Higher doses had progestogenic effects in pregnant rats, associated with prolonged gestation, dystocia and reduced pup survival.
As with other nasal corticosteroid preparations, RYALTRIS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Use in Lactation: It is not known whether the active components of RYALTRIS are excreted in human breast milk after intranasal administration. There are no data from well-controlled human studies on the use of RYALTRIS by nursing mothers. RYALTRIS should be used by nursing mothers only if the potential benefit to the patient outweighs the potential risks to the infant. Patients should also be informed that antihistamines may affect the milk production of a nursing mother.
Olopatadine and mometasone furoate (and/or its metabolites) have both been identified in the milk of lactating rats following oral administration. In rats, pups of mothers administered olopatadine at oral doses of 4 mg/kg/day (approximately 7 times the MRHD for adults by intranasal administration on a mg/m² basis) and above showed decreased bodyweight gain during the nursing period. Pup viability was reduced at 20 mg/kg/day (approximately 35 times the MRHD for adults by intranasal administration on mg/m² basis) and above, but not at 6 mg/kg/day (approximately 10 times the MRHD for adults by intranasal administration on mg/m² basis).